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Clinical Trial Results:
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus

Summary
EudraCT number	2014-002184-14
Trial protocol	ES DE HU IT NL
Global end of trial date	26 Oct 2017

Results information
Results version number	v1(current)
This version publication date	10 Nov 2018
First version publication date	10 Nov 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

IM128-027

ISRCTN number

US NCT number

NCT02265744

WHO universal trial number (UTN)

Sponsor organisation name

Bristol-Myers Squibb

Sponsor organisation address

Chaussée de la Hulpe 185, Brussels, Belgium, 1170

Public contact

EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, clinical.trials@bms.com

Scientific contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

26 Oct 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

26 Oct 2017

Was the trial ended prematurely?

Yes

Main objective of the trial

The primary study objective was to compare the proportion of patients who achieved BICLA response (BICLA response rate) at Day 169 following 24-week treatment with BMS-931699 or placebo administered on a stable background therapy.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

13 Nov 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 53

Country: Number of subjects enrolled

Canada: 5

Country: Number of subjects enrolled

Colombia: 8

Country: Number of subjects enrolled

Romania: 1

Country: Number of subjects enrolled

Spain: 2

Country: Number of subjects enrolled

Argentina: 20

Country: Number of subjects enrolled

Korea, Republic of: 6

Country: Number of subjects enrolled

Taiwan: 9

Country: Number of subjects enrolled

Chile: 17

Country: Number of subjects enrolled

Poland: 14

Country: Number of subjects enrolled

Brazil: 58

Country: Number of subjects enrolled

France: 9

Country: Number of subjects enrolled

Hungary: 4

Country: Number of subjects enrolled

South Africa: 15

Country: Number of subjects enrolled

Peru: 25

Country: Number of subjects enrolled

Mexico: 62

Country: Number of subjects enrolled

Italy: 6

Country: Number of subjects enrolled

Germany: 2

Country: Number of subjects enrolled

Japan: 25

Country: Number of subjects enrolled

Russian Federation: 5

Worldwide total number of subjects

346

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

336

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

730 participants were enrolled and 349 were randomized. 3 were randomized but not treated.Of the 381 who were not randomized,3 had an adverse event, 16 withdrew consent, 1 was lost to follow-up, 339 did not meet study entry criteria and 22 due to other reasons.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

Experimental:12.5mg SC BMS-931699 Weekly

Arm description

12.5mg subcutaneous (SC) injection Weekly dosing

Arm type

Experimental

Investigational medicinal product name

BMS-931699

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

12.5mg subcutaneous (SC) injection Weekly dosing

Experimental:12.5mg SC BMS-931699 Every other Week

Arm description

12.5mg SC injection Every other Week dosing

Arm type

Experimental

Investigational medicinal product name

BMS-931699

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

12.5mg SC injection Every other Week dosing

Experimental: 5mg SC BMS-931699 Every other Week

Arm description

5mg SC injection Every other Week dosing

Arm type

Experimental

Investigational medicinal product name

BMS-931699

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

5mg SC injection Every other Week dosing

Experimental: 1.25mg SC BMS-931699 Every other Week

Arm description

1.25mg SC injection Every other Week dosing

Arm type

Experimental

Investigational medicinal product name

5mg SC injection Every other Week dosing

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

1.25mg SC injection Every other Week dosing

Placebo Comparator: 0mg SC BMS-931699 Weekly

Arm description

0mg SC injection Weekly dosing

Arm type

Placebo

Investigational medicinal product name

BMS-391699 Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

0mg SC injection weekly dosing

Number of subjects in period 1	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Started	69	68	68	70	71
Completed	49	53	51	47	58
Not completed	20	15	17	23	13
Reason not provided by investigator	1	-	-	2	-
Adverse event, serious fatal	-	-	-	2	-
Consent withdrawn by subject	2	-	-	2	-
Adverse event, non-fatal	8	4	9	8	2
Participant request to discontinue	2	2	2	-	-
Pregnancy	1	2	1	1	-
Poor/Non-compliance	1	1	-	-	2
Lost to follow-up	-	-	-	1	-
Subject no longer meets study criteria	-	-	-	-	1
Lack of efficacy	2	4	3	4	5
Administrative reason by sponsor	3	2	2	3	3

Baseline characteristics

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Reporting group title

Experimental:12.5mg SC BMS-931699 Weekly

Reporting group description

12.5mg subcutaneous (SC) injection Weekly dosing

Reporting group title

Experimental:12.5mg SC BMS-931699 Every other Week

Reporting group description

12.5mg SC injection Every other Week dosing

Reporting group title

Experimental: 5mg SC BMS-931699 Every other Week

Reporting group description

5mg SC injection Every other Week dosing

Reporting group title

Experimental: 1.25mg SC BMS-931699 Every other Week

Reporting group description

1.25mg SC injection Every other Week dosing

Reporting group title

Placebo Comparator: 0mg SC BMS-931699 Weekly

Reporting group description

0mg SC injection Weekly dosing

Reporting group values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly	Total
Number of subjects	69	68	68	70	71	346
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0
Adults (18-64 years)	69	67	64	68	68	336
From 65-84 years	0	1	4	2	3	10
85 years and over	0	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (full range (min-max))	41.0 (18 to 64)	39.1 (19 to 68)	41.9 (19 to 69)	38.0 (19 to 69)	40.6 (18 to 68)	-
Sex: Female, Male
Units: Subjects
Female	67	66	65	66	65	329
Male	2	2	3	4	6	17
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	1	1	0	2
Asian	9	7	10	9	8	43
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	6	9	7	7	12	41
White	38	46	41	43	41	209
More than one race	0	0	0	0	0	0
Unknown or Not Reported	16	6	9	10	10	51
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	3	2	3	6	3	17
Not Hispanic or Latino	6	9	9	7	5	36
Unknown or Not Reported	60	57	56	57	63	293

End points

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Reporting group title

Experimental:12.5mg SC BMS-931699 Weekly

Reporting group description

12.5mg subcutaneous (SC) injection Weekly dosing

Reporting group title

Experimental:12.5mg SC BMS-931699 Every other Week

Reporting group description

12.5mg SC injection Every other Week dosing

Reporting group title

Experimental: 5mg SC BMS-931699 Every other Week

Reporting group description

5mg SC injection Every other Week dosing

Reporting group title

Experimental: 1.25mg SC BMS-931699 Every other Week

Reporting group description

1.25mg SC injection Every other Week dosing

Reporting group title

Placebo Comparator: 0mg SC BMS-931699 Weekly

Reporting group description

0mg SC injection Weekly dosing

Primary: Percentage of subjects who achieve BICLA response (BICLA response rate) at Day 169.

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End point title

Percentage of subjects who achieve BICLA response (BICLA response rate) at Day 169.

End point description

BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician’s global assessment (MDGA) of disease activity (“no worsening” is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline; No changes in concomitant medications according to the following criteria: No increase of or addition of a new immunosuppressant agent (azathioprine,mycophenolic acid/mycophenolate mofetil, methotrexate, anti-malarial, leflunomide) over baseline levels; No increase in corticosteroid dose above baseline level outside of those allowed per protocol.

End point type

Primary

End point timeframe

At Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Percentage
number (confidence interval 90%)	59.4 (49.7 to 69.1)	63.2 (53.6 to 72.9)	57.4 (47.5 to 67.2)	58.6 (48.9 to 68.3)	59.2 (49.6 to 68.8)

P-value of Chi-sq test of 12.5mg dose Wkly vs. pbo

Comparison groups

Experimental:12.5mg SC BMS-931699 Weekly v Placebo Comparator: 0mg SC BMS-931699 Weekly

Number of subjects included in analysis

140

Analysis specification

Pre-specified

Analysis type

P-value

= 0.9745

Method

Chi-squared

Confidence interval

P-value of Chi-sq test of 12.5mg dose EOW vs. pbo

Comparison groups

Experimental:12.5mg SC BMS-931699 Every other Week v Placebo Comparator: 0mg SC BMS-931699 Weekly

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

P-value

= 0.6217

Method

Chi-squared

Confidence interval

P-value of Chi-sq test of 5mg dose EOW vs. pbo

Comparison groups

Experimental: 5mg SC BMS-931699 Every other Week v Placebo Comparator: 0mg SC BMS-931699 Weekly

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

P-value

= 0.8295

Method

Chi-squared

Confidence interval

P-value of Chi-sq test of 1.25mg dose EOW vs. pbo

Comparison groups

Placebo Comparator: 0mg SC BMS-931699 Weekly v Experimental: 1.25mg SC BMS-931699 Every other Week

Number of subjects included in analysis

141

Analysis specification

Pre-specified

Analysis type

P-value

= 0.9439

Method

Chi-squared

Confidence interval

Secondary: Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 169

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End point title

Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 169

End point description

SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(X) Response is defined as: a reduction in Day 1 SLEDAI-2K disease activity score of >= X points; no worsening of disease (defined as an increase of >= 30mm on a 100mm VAS from Day 1 as measured by the MDGA; and no new BILAG-2004 Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system scores

End point type

Secondary

End point timeframe

At Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Percentage
number (confidence interval 90%)
SRI (4)\|	55.1 (45.2 to 64.9)	48.5 (38.6 to 58.5)	39.7 (29.9 to 49.5)	44.3 (34.5 to 54.1)	49.3 (39.5 to 59.1)
SRI (5)\|	37.7 (28.1 to 47.3)	29.4 (20.3 to 38.5)	27.9 (19.0 to 36.9)	31.4 (22.3 to 40.6)	33.8 (24.6 to 43.0)
SRI (6)\|	33.8 (24.6 to 43.0)	31.4 (22.3 to 40.6)	27.9 (19.0 to 36.9)	26.5 (17.7 to 35.3)	37.7 (28.1 to 47.3)

No statistical analyses for this end point

Secondary: Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 85

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End point title

Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 85

End point description

SRI is the Systemic Lupus Erythematosus (SLE) Responder Index; SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(X) Response is defined as: a reduction in Day 1 SLEDAI-2K disease activity score of >= X points; no worsening of disease (defined as an increase of >= 30mm on a 100mm VAS from Day 1 as measured by the MDGA; and no new BILAG-2004 Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system scores

End point type

Secondary

End point timeframe

At Day 85

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Percentage
number (confidence interval 90%)
SRI (4)\|	49.3 (39.4 to 59.2)	48.5 (38.6 to 58.5)	41.2 (31.4 to 51.0)	47.1 (37.3 to 57.0)	43.7 (34.0 to 53.3)
SRI (5)\|	29.0 (20.0 to 38.0)	32.4 (23.0 to 41.7)	25.0 (16.4 to 33.6)	31.4 (22.3 to 40.6)	28.2 (19.4 to 36.9)
SRI (6)\|	29.0 (20.0 to 38.0)	30.9 (21.7 to 40.1)	25.0 (16.4 to 33.6)	31.4 (22.3 to 40.6)	26.8 (18.1 to 35.4)

No statistical analyses for this end point

Secondary: Percentage of subjects with BICLA response (BICLA response rate) at Day 85

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End point title

Percentage of subjects with BICLA response (BICLA response rate) at Day 85

End point description

End point type

Secondary

End point timeframe

At Day 85

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Percentage
number (confidence interval 90%)	69.6 (60.5 to 78.7)	64.7 (55.2 to 74.2)	57.4 (47.5 to 67.2)	57.1 (47.4 to 66.9)	54.9 (45.2 to 64.6)

No statistical analyses for this end point

Secondary: Mean change from baseline in CLASI score

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End point title

Mean change from baseline in CLASI score

End point description

Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 for CLASI activity and 0 to 70 for CLASI damage, with higher scores denoting greater disease activity or damage.

End point type

Secondary

End point timeframe

At Day 85 and Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Score
arithmetic mean (standard deviation)
Day 85\|	-2.31 ( 3.107 )	-3.20 ( 4.718 )	-1.69 ( 2.319 )	-1.82 ( 4.515 )	-3.11 ( 4.239 )
Day 169\|	-3.17 ( 4.387 )	-3.78 ( 5.555 )	-2.47 ( 2.824 )	-2.94 ( 4.897 )	-3.57 ( 4.177 )

No statistical analyses for this end point

Secondary: Percentage of subjects with an improvement of >4 or a decrease of >50% from baseline in their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score

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End point title

Percentage of subjects with an improvement of >4 or a decrease of >50% from baseline in their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score

End point description

CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 for CLASI activity and 0 to 70 for CLASI damage, with higher scores denoting greater disease activity or damage.

End point type

Secondary

End point timeframe

At Day 85 and Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Percentage
number (confidence interval 90%)	39.3 (29.1 to 49.6)	46.9 (36.6 to 57.1)	34.5 (24.2 to 44.7)	36.1 (26.0 to 46.2)	42.4 (32.4 to 52.4)

No statistical analyses for this end point

Secondary: Change from baseline in arthritis, as assessed by American College of Rheumatology (ACR) 28-joint count of tender and swollen joints

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End point title

Change from baseline in arthritis, as assessed by American College of Rheumatology (ACR) 28-joint count of tender and swollen joints

End point description

Mean Change from Baseline Over Time; Measured by Disease Activity Score 28: A single score on a continuous scale (0–9.4). The level of RA disease activity can be interpreted as low (DAS28 <=3.2),moderate (3.2 < DAS28 <=5.1), or as high disease activity (DAS28 > 5.1)

End point type

Secondary

End point timeframe

At Day 85 and Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Disease Activity Score 28
arithmetic mean (standard deviation)	-4.63 ( 4.719 )	-4.63 ( 5.311 )	-4.75 ( 4.985 )	-4.42 ( 5.626 )	-3.84 ( 4.922 )

No statistical analyses for this end point

Secondary: Change from baseline in BILAG-2004 score of systemic lupus erythematosus (SLE) activity over time

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End point title

Change from baseline in BILAG-2004 score of systemic lupus erythematosus (SLE) activity over time

End point description

Overall British Isles Lupus Assessment Group-2004 score, BILAG Scores: A=Severe disease activity, B=Moderate disease activity, C=Mild disease, D=Inactive disease but previously affected, E=System never involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.

End point type

Secondary

End point timeframe

At Day 85 and Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Score
arithmetic mean (standard deviation)
BILAG-2004 Score Day 85\|	-10.31 ( 7.480 )	-8.83 ( 7.749 )	-7.07 ( 7.299 )	-8.66 ( 6.598 )	-7.94 ( 8.008 )
BILAG-2004 Score Day 169\|	-11.50 ( 6.983 )	-10.46 ( 7.808 )	-8.98 ( 6.719 )	-9.73 ( 5.478 )	-9.78 ( 7.590 )

No statistical analyses for this end point

Secondary: Cumulative corticosteroid and immunosuppressant use over time

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End point title

Cumulative corticosteroid and immunosuppressant use over time

End point description

The cumulative corticosteroids use and immunosuppressants use over time

End point type

Secondary

End point timeframe

Up to one day prior to the first dose of long-term extension period or up to 42 days post last short-term dose date, which ever is earlier

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Percentage
number (not applicable)
Corticosteroids: Oral\|	89.9	82.4	86.8	84.3	94.4
Corticosteroids: Oral inhalation\|	0	0	1.5	0	0
Immunosuppressant\|	46.4	63.2	38.2	51.4	59.2
Immunosuppressant Azathioprine\|	23.2	29.4	14.7	28.6	33.8
Immunosuppressant Methotrexate\|	26.1	35.3	25.0	24.3	26.8

No statistical analyses for this end point

Secondary: Number of subjects with Adverse Events (AEs), Serious adverse events (SAEs), and pre-established Events of Special Interest

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End point title

Number of subjects with Adverse Events (AEs), Serious adverse events (SAEs), and pre-established Events of Special Interest

End point description

Although there are no identified risks for BMS-931699, BMS has developed a list of events of special interest for the BMS-931699 program based on the known biologic class effects, the mechanism of action of BMS-931699, overall potential consequences of mmunosuppression, and preliminary data from unblinded clinical trials. Event categories of special interest for this study may include, but are not limited to: Infections, Autoimmunity, Malignancies, Injection-related reactions

End point type

Secondary

End point timeframe

On or after the first dose date of short-term study medication and up to 42 days post last short-term dose date or up to the day prior to the first dose of long-term extension period, whichever is earlier

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Serious Adverse Events\|	5	5	9	8	6
Related SAEs\|	3	3	5	0	1
Related Adverse Events\|	33	30	29	19	19
AEs of Malignancies\|	0	0	0	0	0
AEs of Infections and Infestations\|	38	41	35	39	30
AEs Leading to Discontinuation\|	8	5	9	9	3
Adverse Events of Autoimmunity\|	4	0	0	0	1
Most Common Adverse Events\|	59	56	60	59	62
Adverse Events of Local Injection Reactions\|	10	8	10	3	4

No statistical analyses for this end point

Secondary: Percentage of subjects with clinically significant changes in vital signs

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End point title

Percentage of subjects with clinically significant changes in vital signs

End point description

HEART RATE (BPM): HR > 100 AND CHG FROM BSL > 30 OR HR < 55 AND CHG FROM BSL < -15; SYSTOLIC BLOOD PRESSURE (MMHG) SYSBP > 140 AND CHG FROM BSL > 20 OR SYSBP < 90 AND CHG FROM BSL < -20; DIABP > 90 AND CHG FROM BSL > 10 OR DIABP < 55 AND CHG FROM BSL < -10; RESPIRATION RATE (PER MIN) RESP > 16 OR RESP CHG FROM BSL > 10; TEMPERATURE (C) TEMP > 38.3 OR TEMP CHG FROM BSL > 1.6

End point type

Secondary

End point timeframe

At Day 85 and Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Percentage
number (not applicable)
HEART RATE (BPM) SITTING\|	2.9	5.9	2.9	2.9	5.6
HEART RATE (BPM) STANDING\|	4.3	5.9	7.4	7.1	5.7
HEART RATE (BPM) SUPINE\|	0	0	0	0	0
SYSTOLIC BLOOD PRESSURE (MMHG) SITTING\|	11.6	17.6	10.3	10.0	15.5
SYSTOLIC BLOOD PRESSURE (MMHG) STANDING\|	14.5	14.7	8.8	11.4	20.0
SYSTOLIC BLOOD PRESSURE (MMHG) SUPINE\|	0	0	0	0	0
DIASTOLIC BLOOD PRESSURE (MM HG) SITTING\|	26.1	17.6	11.8	17.1	9.9
DIASTOLIC BLOOD PRESSURE (MM HG) STANDING\|	18.8	27.9	25.0	21.4	20.0
DIASTOLIC BLOOD PRESSURE (MM HG) SUPINE\|	0	0	0	0	0
RESPIRATION RATE (PER MIN)\|	85.5	82.4	75.0	70.0	81.7
TEMPERATURE (C)\|	0	0	1.5	1.4	1.4

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant electrocardiogram (ECG) abnormalities

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End point title

Number of subjects with clinically significant electrocardiogram (ECG) abnormalities

End point description

QTC Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF

End point type

Secondary

End point timeframe

Up to 42 days post last dose of short-term double-blind study medication or up to the day prior to the start of long-term extension period, whichever is earlier.

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
QTC Fredericia (msec) <= 450\|	56	58	58	56	65
QTC Fredericia (msec) 450< To <= 480\|	12	8	5	11	5
QTC Fredericia (msec) 480 < to <= 500\|	0	1	2	0	1
QTC Fredericia (msec) > 500\|	1	1	3	3	0
PR Interval (msec) <= 200\|	69	68	64	66	68
PR Interval (msec) > 200\|	0	0	4	4	3
QRS Interval (msec) <= 120\|	68	67	66	67	70
QRS Interval (msec) > 120\|	1	1	2	3	1
Change from baseline in QTCF (msec) <= 30\|	66	59	54	55	62
Change from baseline in QTCF (msec) 30 To <= 60\|	2	7	7	2	5
Change from baseline in QTCF (msec) > 60\|	0	2	3	3	0

No statistical analyses for this end point

Secondary: Ctrough: Trough level serum concentration of BMS-931699 at time points specified

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End point title

Ctrough: Trough level serum concentration of BMS-931699 at time points specified

End point description

Pharmacokinetics of BMS-931699 derived from serum concentration versus time data; Pharmacokinetic Population: defined as all subjects who receive any study medication and have any available concentration-time data.

End point type

Secondary

End point timeframe

Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	68	68	68	70	71
Units: ng/mL
arithmetic mean (standard deviation)	2040 ( 945.57 )	640.8 ( 436.35 )	207.1 ( 149.53 )	62.2 ( 56.83 )	0 ( 0 )

No statistical analyses for this end point

Secondary: Serum biomarkers C3, C4

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End point title

Serum biomarkers C3, C4

End point description

Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169

End point type

Secondary

End point timeframe

At Day 85 and Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: g/L
arithmetic mean (standard deviation)
C3, Baseline\|	1.068 ( 0.3405 )	1.029 ( 0.3265 )	0.990 ( 0.3318 )	1.028 ( 0.3149 )	0.991 ( 0.2641 )
C3, Day 85\|	1.037 ( 0.3024 )	1.014 ( 0.3428 )	1.030 ( 0.3225 )	1.083 ( 0.3124 )	0.986 ( 0.3005 )
C3, Day 169\|	1.045 ( 0.3405 )	1.010 ( 0.3557 )	1.027 ( 0.3528 )	1.077 ( 0.3256 )	0.992 ( 0.2981 )
C4, Baseline\|	0.201 ( 0.1084 )	0.185 ( 0.1088 )	0.177 ( 0.0861 )	0.202 ( 0.0984 )	0.183 ( 0.0824 )
C4, Day 85\|	0.206 ( 0.1037 )	0.195 ( 0.1079 )	0.190 ( 0.0875 )	0.215 ( 0.0965 )	0.179 ( 0.0824 )
C4, Day 169\|	0.212 ( 0.1161 )	0.185 ( 0.1014 )	0.187 ( 0.0941 )	0.207 ( 0.0927 )	0.184 ( 0.0896 )

No statistical analyses for this end point

Secondary: Serum biomarkers: Anti-Nuclear Antibodies (ANA)

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End point title

Serum biomarkers: Anti-Nuclear Antibodies (ANA)

End point description

End point type

Secondary

End point timeframe

At Day 85 and Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	66	67	70
Units: Percentage
number (not applicable)
Baseline Negative Day 85 Negative\|	62.5	57.1	100.0	50.0	60.0
Baseline Negative Day 85 Positive\|	37.5	42.9	0	50.0	40.0
Baseline Positive Day 85 Negative\|	11.3	3.4	1	2.0	0
Baseline Positive Day 85 Positive\|	88.7	96.6	98.2	98.0	100.0
Baseline Negative Day 169 Negative\|	71.4	33.3	100.0	57.1	40.0
Baseline Negative Day 169 Positive\|	28.6	66.7	0	42.9	60.0
Baseline Positive Day 169 Negative\|	9.3	2.0	5.8	4.3	1.8
Baseline Positive Day 169 Positive\|	90.7	98.0	94.2	95.7	98.2

No statistical analyses for this end point

Secondary: Short term: Receptor occupancy over time

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End point title

Short term: Receptor occupancy over time

End point description

Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy

End point type

Secondary

End point timeframe

At Day 85 and Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	66	67	71
Units: Percentage
arithmetic mean (standard deviation)
%CD4+ RO Baseline\|	0 ( 0 )	0 ( 0 )	0 ( 0 )	0 ( 0 )	0 ( 0 )
%CD4+ RO Day 85\|	95.722 ( 12.1298 )	83.244 ( 28.9616 )	70.520 ( 32.9107 )	37.155 ( 31.2927 )	0.350 ( 0.5997 )
%CD4+ RO Day 169\|	92.390 ( 22.1377 )	77.210 ( 29.3976 )	74.286 ( 28.5105 )	44.115 ( 34.3707 )	0.334 ( 0.4460 )
%CD8+ RO Baseline\|	0 ( 0 )	0 ( 0 )	0 ( 0 )	0 ( 0 )	0 ( 0 )
%CD8+ RO Day 85\|	95.831 ( 7.6571 )	81.730 ( 30.4345 )	68.960 ( 32.0543 )	32.516 ( 29.7242 )	0.160 ( 0.3120 )
%CD8+ RO Day 169\|	92.043 ( 20.6963 )	74.726 ( 33.0060 )	69.850 ( 30.5880 )	40.989 ( 31.9867 )	0.235 ( 0.5438 )

No statistical analyses for this end point

Secondary: Percentage of subjects with BMS-931699 induced antibody response over time point specified

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End point title

Percentage of subjects with BMS-931699 induced antibody response over time point specified

End point description

Immunogenicity defined as positive for anti-drug antibodies post-baseline measurement if baseline missing or negative. If baseline is positive, then immunogenicity is defined as a positive post-baseline measurement with titer value 4 times greater than baseline. (A) all subjects with a laboratory reported positive antibody responses to BMS-931699 during the short-term double-blind treatment period are included. Overall: At least one positive sample relative to baseline during short-term double-blind and follow-up period.

End point type

Secondary

End point timeframe

Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	26	34	34	41	0 ^[1]
Units: Percentage
number (not applicable)
% with Neutralizing activity\|	23.1	41.2	64.7	34.1
% with Neutralizing activity (Baseline)\|	0	5.9	0	0
% with Neutralizing activity (Overall)\|	23.1	35.3	64.7	34.1

Notes
[1] - No BMS-931699 induced antibody response observed for placebo

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY I

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY I

End point description

HEMATOLOGY I: ERYTHROCYTE/PLATELET ATTRIBUTES HEMOGLOBIN HB G/L L < 0.85×PRE-RX; HEMATOCRIT HCT VOL L < 0.85×PRE-RX; PLATELET COUNT PLAT X10*9 C/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN PLATELET COUNT PLAT X10*9 C/L L < 0.85×LLN IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >= LLN OR < 0.85×PRE-RX IF PRE-RX < LLN; ERYTHROCYTES RBC X10*12 C/L L < 0.85×PRE-RX HEMATOLOGY II QUANTITATIVE WBC : LEUKOCYTES WBC X10*9 C/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF LLN <= PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; LEUKOCYTES WBC X10*9 C/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF LLN <= PRE-RX <= ULN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Erythrocytes Low\|	4	4	6	3	5
Erythrocytes High\|	9999	9999	9999	9999	9999
Hematocrit Low\|	6	10	5	5	8
Hematocrit High\|	9999	9999	9999	9999	9999
Hemoglobin Low\|	4	4	5	4	5
Hemoglobin High\|	9999	9999	9999	9999	9999
Platelet count low\|	1	1	1	1	2
Platelet count high\|	0	0	0	1	0
Quantitative WBC: Leukocytes low\|	12	18	12	16	16
Quantitative WBC: Leukocytes high\|	1	1	0	3	1

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY II

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY II

End point description

WBC DIFFERENTIAL COUNT: BASOPHILS (ABSOLUTE) BASOA X10*9 C/L H > 0.4; BLASTS (ABSOLUTE) BLASA X10*9 C/L H > 0; EOSINOPHILS (ABSOLUTE) EOSA X10*9 C/L H > 0.75; LYMPHOCYTES (ABSOLUTE) LYMPA X10*9 C/L H > 7.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10*9 C/L L < 0.75; MONOCYTES (ABSOLUTE) MONOA X10*9 C/L H > 2; NEUTROPHILS (ABSOLUTE) NEUTA X10*9 C/L L < 1.5 IF PRE-RX IS MISSING OR < 1.5 IF PRE-RX >= 1.5 OR < 0.85×PRE-RX IF PRE-RX < 1.5; COAGULATION APTT SEC H > 1.5×ULN; INTL NORMALIZED RATIO (INR) INR FRACTION H > 1.5×ULN PROTHROMBIN TIME (PT) PT SEC H > 1.5×ULN

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Basophils (Absolute) Low\|	9999	9999	9999	9999	9999
Basophils (Absolute) High\|	0	0	0	0	0
Blasts (Absolute) Low\|	0	9999	0	0	0
Blasts (Absolute) High\|	0	0	0	0	0
Eosinophils (Absolute) Low\|	9999	9999	9999	9999	9999
Eosinophils (Absolute) High\|	3	0	0	2	1
Lymphocytes (Absolute) Low\|	21	29	24	25	25
Lymphocytes (Absolute) High\|	0	0	0	0	0
Monocytes (Absolute) High\|	9999	9999	9999	9999	9999
Monocytes (Absolute) Low\|	0	0	0	0	0
Neutrophils (Absolute) Low\|	10	8	5	7	4
Neutrophils (Absolute) High\|	9999	9999	9999	9999	9999

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : LIVER FUNCTION TESTS

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests : LIVER FUNCTION TESTS

End point description

LIVER FUNCTION TESTS:ALKALINE PHOSPHATASE (ALP) ALP U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT DBILI UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN G-GLUTAMYL TRANSFERASE (GGT) GGT U/L H > 1.15×ULN IF PRE-RX IS MISSING OR > 1.15×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN BILIRUBIN, TOTAL TBILI UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Alanine Aminotransferase Low\|	9999	9999	9999	9999	9999
Alanine Aminotransferase High\|	12	17	6	9	8
Alkaline Phosphatase Low\|	9999	9999	9999	9999	9999
Alkaline Phosphatase High\|	2	3	2	5	8
Aspartate Aminotransferase Low\|	9999	9999	9999	9999	9999
Aspartate Aminotransferase High\|	10	13	11	8	10
Bilirubin, Direct Low\|	9999	9999	9999	9999	9999
Bilirubin Direct, High\|	0	13	0	1	0
Bilirubin Total, Low\|	9999	9999	9999	9999	9999
Bilirubin Total, High\|	0	0	0	1	1
G-Glutamyl Transferase, Low\|	9999	9999	9999	9999	9999
G-Glutamyl Transferase, High\|	18	14	16	15	13

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: KIDNEY FUNCTION TESTS

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests: KIDNEY FUNCTION TESTS

End point description

KIDNEY FUNCTION TESTS:BLOOD UREA NITROGEN BUN MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN CREATININE CREAT UMOL/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.33×PRE-RX IF PRE-RX > ULN GLOMERULAR FILTRATION RATE, CALC. (MDRD) GFRC ML/S/M*2 L < 0.8×PRE-RX; UREA UREA MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Blood Urea Nitrogen, Low\|	9999	9999	9999	9999	9999
Blood Urea Nitrogen, High\|	9	11	3	14	10
Creatinine, Low\|	9999	9999	9999	9999	9999
Creatinine, High\|	2	0	0	2	1
GLOMERULAR FILTRATION RATE, CALC. Low\|	0	0	0	0	0
GLOMERULAR FILTRATION RATE, CALC. High\|	9999	9999	9999	9999	9999
Urea, Low\|	9999	9999	9999	9999	9999
Urea, High\|	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests ELECTROLYTES 1

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests ELECTROLYTES 1

End point description

CALCIUM, TOTAL CA MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CALCIUM, TOTAL CA MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; CHLORIDE, SERUM CL MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CHLORIDE, SERUM CL MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN;

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Calcium, Total, Low\|	0	0	1	0	0
Calcium, Total, High\|	0	0	0	0	0
Chloride, Serum, Low\|	0	0	0	0	0
Chloride, Serum, High\|	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 2

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 2

End point description

BICARBONATE HCO3 MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; BICARBONATE HCO3 MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; POTASSIUM, SERUM K MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; POTASSIUM, SERUM K MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; MAGNESIUM, SERUM MG MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN MAGNESIUM, SERUM MG MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Bicarbonate, Low\|	0	0	0	0	0
Bicarbonate, High\|	0	0	0	0	0
Magnesium, Serum, Low\|	0	0	0	0	0
Magnesium, Serum, High\|	0	0	0	0	0
Potassium, Serum, Low\|	1	0	1	1	1
Potassium, Serum, High\|	0	0	1	1	0

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 3

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 3

End point description

SODIUM, SERUM NA MMOL/L H > 1.05×ULN IF PRE-RX IS MISSING OR > 1.05×ULN IF PRE-RX <= ULN OR > 1.05×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN SODIUM, SERUM NA MMOL/L L < 0.95×LLN IF PRE-RX IS MISSING OR < 0.95×LLN IF PRE-RX >= LLN OR < 0.95×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN PHOSPHORUS, INORGANIC PHOS MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PHOSPHORUS, INORGANIC PHOS MMOL/L L < 0.85×LLN IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >=LLN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Sodium, Serum Low\|	0	0	0	0	0
Sodium, Serum High\|	0	0	0	0	0
Phosphorus, Inorganic, Low\|	0	2	4	1	0
Phosphorus, Inorganic, High\|	0	0	0	1	0

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 1

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 1

End point description

GLUCOSE TESTS:GLUCOSE, FASTING SERUM GLUCF MMOL/L H > 1.3×ULN IF PRE-RX IS MISSING OR > 1.3×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN GLUCOSE, FASTING SERUM GLUCF MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; PROTEIN TESTS:ALBUMIN ALB G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN PROTEIN, TOTAL TPRO G/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PROTEIN, TOTAL TPRO G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Glucose, Fasting serum, Low\|	1	3	0	4	5
Glucose, Fasting Serum, High\|	3	3	0	0	4
Albumin, Low\|	1	2	2	2	1
Albumin, High\|	0	0	0	0	0
Protein, Total, Low\|	0	0	1	1	0
Protein, Total, High\|	0	0	1	1	0

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 2

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 2

End point description

OTHER CHEMISTRY TESTING LIPID TESTS: CHOLESTEROL, TOTAL (TC) CHOL MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN TRIGLYCERIDES, FASTING TRIGF MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN PANCREATIC TESTS: AMYLASE, TOTAL AMYL U/L H > 1.5×ULN; LIPASE, TOTAL (TURBIDIMETRIC ASSAY) LIPA U/L H > 1.5×ULN; LIPASE, TOTAL (COLORIMETRIC ASSAY) LIPAC U/L H > 1.5×ULN; ENDOCRINE TESTS:CORTISOL, AM CORTA NMOL/L L < 138 THYROID STIMULATING HORMONE (TSH) TSH MU/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Cholesterol, Total (TC) Low\|	9999	9999	9999	9999	9999
Cholesterol, Total (TC) High\|	5	4	12	10	8
Triglycerides, Fasting Low\|	9999	9999	9999	9999	9999
Triglycerides, Fasting High\|	12	13	12	10	8
Amylase, Total Low\|	9999	9999	9999	9999	9999
Amylase, Total High\|	0	0	0	0	0
Lipase, Total (Colorimetric Assay) Low\|	9999	9999	9999	9999	9999
Lipase, Total (Colorimetric Assay) High\|	0	0	1	0	0
Lipase, Total (Turbidimetric Assay) Low\|	9999	9999	9999	9999	9999
Lipase, Total (Turbidimetric Assay) High\|	0	0	1	0	0
Thyroid Stimulating Hormone, Low\|	9999	9999	9999	9999	9999
Thyroid Stimulating Hormone, High\|	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 3

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 3

End point description

OTHER CHEMISTRY TESTING CARDIAC TESTS: CREATINE KINASE (CK) CK U/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN; TROPONIN-I, CARDIAC SPECIFIC TROI UG/L H > ULN; METABOLITE TESTS:URIC ACID URIC MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; CHEM TEST, MULTI INDICATIONS : LACTATE DEHYDROGENASE (LD) LD U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Creatine Kinase Low\|	9999	9999	9999	9999	9999
Creatine Kinase High\|	5	5	3	3	1
TROPONIN-I, CARDIAC SPECIFIC Low\|	9999	9999	9999	9999	9999
TROPONIN-I, CARDIAC SPECIFIC High\|	0	0	0	0	0
Uric Acid, Low\|	9999	9999	9999	9999	9999
Uric Acid, High\|	0	0	0	0	0
Lactate dehydrogenase (LD) low\|	9999	9999	9999	9999	9999
Lactate dehydrogenase (LD) high\|	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : IMMUNOLOGY

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests : IMMUNOLOGY

End point description

IMMUNE ACTIVATION MARKERS:C-REACTIVE PROTEIN (CRP) CRP MG/L H > 1.5×ULN; CRP, HIGH SENSITIVITY CRPHS MG/L H > 1.5×ULN;

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
C-Reactive Protein (CRP) Low\|	9999	9999	9999	9999	9999
C-Reactive Protein (CRP) High\|	19	18	22	18	22
CRP, High Sensitivity Low\|	9999	9999	9999	9999	9999
CRP, High Senstivity High\|	0	0	1	0	0

No statistical analyses for this end point

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : URINALYSIS

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End point title

Number of subjects with clinically significant abnormalities in general laboratory tests : URINALYSIS

End point description

QUALITATIVE URINE CHEMISTRY: BLOOD, URINE UBLD N/A H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 GLUCOSE, URINE UGLU N/A H >= 1 IF PRE-RX IS MISSING OR >= 1 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 PROTEIN, URINE UPRO UNKNOWN H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 URINALYSIS II URINE WBC + RBC ; RBC, URINE URBC HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2 WBC, URINE UWBC HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2

End point type

Secondary

End point timeframe

Up to 42 days post last dose of study medication in short-term or long-term extension period

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Subjects
Blood, Urine, Low\|	9999	9999	9999	9999	9999
Blood, Urine, High\|	18	21	20	21	20
Glucose, Urine, Low\|	9999	9999	9999	9999	9999
Glucose, Urine, High\|	2	2	0	0	1
Protein, Urine, Low\|	9999	9999	9999	9999	9999
Protein, Urine, High\|	7	7	13	7	10
RBC, Urine, Low\|	9999	9999	9999	9999	9999
RBC, Urine, High\|	18	19	13	17	18
WBC, Urine, Low\|	9999	9999	9999	9999	9999
WBC, Urine, High\|	28	29	31	31	25

No statistical analyses for this end point

Secondary: Change from baseline in the SLEDAI-2K score of SLE activity over time

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End point title

Change from baseline in the SLEDAI-2K score of SLE activity over time

End point description

Systemic Lupus Erythematosus Disease Activity Index, SLEDAI; Version 2000, also known as SLEDAI-2K. The SLEDAI-2K score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.

End point type

Secondary

End point timeframe

At Day 85 and Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Score
arithmetic mean (standard deviation)
SLEDAI-2K Score Day 85	-3.61 ( 3.345 )	-3.24 ( 3.320 )	-3.17 ( 3.304 )	-4.02 ( 3.960 )	-3.29 ( 3.953 )
SLEDAI-2K Score Day 169	-4.88 ( 3.370 )	-4.17 ( 4.064 )	-3.98 ( 3.478 )	-4.82 ( 4.078 )	-4.15 ( 3.728 )

No statistical analyses for this end point

Secondary: Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) over time

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End point title

Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) over time

End point description

Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) visual anlalog scale (VAS), where 0 cm = very good and 10 cm = very bad.

End point type

Secondary

End point timeframe

At Day 85 and Day 169

End point values	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Number of subjects analysed	69	68	68	70	71
Units: Score
arithmetic mean (standard deviation)
MDGA Score Day 85	-28.77 ( 18.193 )	-23.87 ( 20.321 )	-21.00 ( 20.596 )	-20.55 ( 17.233 )	-23.83 ( 20.752 )
MDGA Score Day 169	-29.30 ( 17.371 )	-26.87 ( 21.284 )	-28.68 ( 19.919 )	-26.71 ( 18.182 )	-25.28 ( 19.952 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from onset on or after the first dose date of study medication and up to 42 days post last dose.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.1

Reporting group title

Experimental:12.5mg SC BMS-931699 Weekly

Reporting group description

Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly.

Reporting group title

Experimental:12.5mg SC BMS-931699 Every other Week

Reporting group description

Subjects received 1.25 mg lulizumab pegol SC injection EOW.

Reporting group title

Experimental: 5mg SC BMS-931699 Every other Week

Reporting group description

Subjects received 5 mg SC injection of lulizumab pegol EOW.

Reporting group title

Experimental: 1.25mg SC BMS-931699 Every other Week

Reporting group description

Subjects received 12.5 mg SC injection of lulizumab pegol EOW.

Reporting group title

Placebo Comparator: 0mg SC BMS-931699 Weekly

Reporting group description

Subjects received 12.5 mg SC injection of lulizumab pegol weekly.

Serious adverse events	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 71 (8.45%)	8 / 70 (11.43%)	9 / 68 (13.24%)	5 / 68 (7.35%)	5 / 69 (7.25%)
number of deaths (all causes)	0	2	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	1 / 68 (1.47%)	1 / 69 (1.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Imminent abortion
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	1 / 68 (1.47%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	1 / 69 (1.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	1 / 68 (1.47%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Serum sickness
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	1 / 68 (1.47%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleurisy
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	1 / 68 (1.47%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 71 (1.41%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Incisional hernia
subjects affected / exposed	0 / 71 (0.00%)	1 / 70 (1.43%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiac failure congestive
subjects affected / exposed	0 / 71 (0.00%)	1 / 70 (1.43%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	0 / 71 (0.00%)	1 / 70 (1.43%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebral haemorrhage
subjects affected / exposed	0 / 71 (0.00%)	1 / 70 (1.43%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Optic neuritis
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	1 / 69 (1.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Putamen haemorrhage
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	1 / 69 (1.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	1 / 69 (1.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vertebrobasilar insufficiency
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	1 / 68 (1.47%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Neutropenia
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	1 / 68 (1.47%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Lupus enteritis
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	1 / 68 (1.47%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	1 / 69 (1.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	1 / 71 (1.41%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Lupus nephritis
subjects affected / exposed	2 / 71 (2.82%)	1 / 70 (1.43%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	1 / 68 (1.47%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 71 (0.00%)	1 / 70 (1.43%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Systemic lupus erythematosus
subjects affected / exposed	0 / 71 (0.00%)	2 / 70 (2.86%)	2 / 68 (2.94%)	1 / 68 (1.47%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	1 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Infections and infestations
Cellulitis
subjects affected / exposed	3 / 71 (4.23%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	1 / 68 (1.47%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	1 / 71 (1.41%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infectious mononucleosis
subjects affected / exposed	0 / 71 (0.00%)	1 / 70 (1.43%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lung infection
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	1 / 69 (1.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	1 / 68 (1.47%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	0 / 68 (0.00%)	0 / 68 (0.00%)	1 / 69 (1.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Zika virus infection
subjects affected / exposed	0 / 71 (0.00%)	1 / 70 (1.43%)	0 / 68 (0.00%)	0 / 68 (0.00%)	0 / 69 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Experimental:12.5mg SC BMS-931699 Weekly	Experimental:12.5mg SC BMS-931699 Every other Week	Experimental: 5mg SC BMS-931699 Every other Week	Experimental: 1.25mg SC BMS-931699 Every other Week	Placebo Comparator: 0mg SC BMS-931699 Weekly
Total subjects affected by non serious adverse events
subjects affected / exposed	62 / 71 (87.32%)	59 / 70 (84.29%)	60 / 68 (88.24%)	56 / 68 (82.35%)	59 / 69 (85.51%)
Nervous system disorders
Dizziness
subjects affected / exposed	3 / 71 (4.23%)	5 / 70 (7.14%)	1 / 68 (1.47%)	3 / 68 (4.41%)	3 / 69 (4.35%)
occurrences all number	4	5	1	3	3
Headache
subjects affected / exposed	10 / 71 (14.08%)	5 / 70 (7.14%)	7 / 68 (10.29%)	9 / 68 (13.24%)	10 / 69 (14.49%)
occurrences all number	10	5	13	13	11
Migraine
subjects affected / exposed	2 / 71 (2.82%)	1 / 70 (1.43%)	4 / 68 (5.88%)	1 / 68 (1.47%)	0 / 69 (0.00%)
occurrences all number	2	1	4	1	0
Blood and lymphatic system disorders
Leukopenia
subjects affected / exposed	0 / 71 (0.00%)	3 / 70 (4.29%)	3 / 68 (4.41%)	3 / 68 (4.41%)	5 / 69 (7.25%)
occurrences all number	0	4	3	4	6
Lymphopenia
subjects affected / exposed	0 / 71 (0.00%)	2 / 70 (2.86%)	3 / 68 (4.41%)	4 / 68 (5.88%)	4 / 69 (5.80%)
occurrences all number	0	2	4	6	5
General disorders and administration site conditions
Chest pain
subjects affected / exposed	4 / 71 (5.63%)	1 / 70 (1.43%)	2 / 68 (2.94%)	1 / 68 (1.47%)	1 / 69 (1.45%)
occurrences all number	4	1	2	1	1
Injection site pain
subjects affected / exposed	4 / 71 (5.63%)	2 / 70 (2.86%)	4 / 68 (5.88%)	3 / 68 (4.41%)	2 / 69 (2.90%)
occurrences all number	9	27	6	7	27
Injection site reaction
subjects affected / exposed	0 / 71 (0.00%)	0 / 70 (0.00%)	3 / 68 (4.41%)	2 / 68 (2.94%)	4 / 69 (5.80%)
occurrences all number	0	0	5	3	7
Pyrexia
subjects affected / exposed	2 / 71 (2.82%)	4 / 70 (5.71%)	3 / 68 (4.41%)	1 / 68 (1.47%)	1 / 69 (1.45%)
occurrences all number	2	5	7	1	2
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	11 / 71 (15.49%)	5 / 70 (7.14%)	5 / 68 (7.35%)	1 / 68 (1.47%)	7 / 69 (10.14%)
occurrences all number	12	5	7	1	8
Nausea
subjects affected / exposed	4 / 71 (5.63%)	5 / 70 (7.14%)	5 / 68 (7.35%)	0 / 68 (0.00%)	5 / 69 (7.25%)
occurrences all number	5	8	5	0	6
Psychiatric disorders
Insomnia
subjects affected / exposed	4 / 71 (5.63%)	2 / 70 (2.86%)	1 / 68 (1.47%)	3 / 68 (4.41%)	2 / 69 (2.90%)
occurrences all number	4	2	1	3	2
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	4 / 71 (5.63%)	0 / 70 (0.00%)	1 / 68 (1.47%)	1 / 68 (1.47%)	2 / 69 (2.90%)
occurrences all number	5	0	2	1	4
Back pain
subjects affected / exposed	3 / 71 (4.23%)	2 / 70 (2.86%)	1 / 68 (1.47%)	4 / 68 (5.88%)	5 / 69 (7.25%)
occurrences all number	3	3	1	4	5
Neck pain
subjects affected / exposed	2 / 71 (2.82%)	4 / 70 (5.71%)	1 / 68 (1.47%)	0 / 68 (0.00%)	3 / 69 (4.35%)
occurrences all number	2	4	1	0	3
Systemic lupus erythematosus
subjects affected / exposed	2 / 71 (2.82%)	1 / 70 (1.43%)	3 / 68 (4.41%)	2 / 68 (2.94%)	5 / 69 (7.25%)
occurrences all number	2	1	6	2	5
Infections and infestations
Bronchitis
subjects affected / exposed	3 / 71 (4.23%)	1 / 70 (1.43%)	3 / 68 (4.41%)	1 / 68 (1.47%)	4 / 69 (5.80%)
occurrences all number	4	1	3	1	4
Gastroenteritis
subjects affected / exposed	1 / 71 (1.41%)	1 / 70 (1.43%)	2 / 68 (2.94%)	3 / 68 (4.41%)	8 / 69 (11.59%)
occurrences all number	1	1	2	3	8
Influenza
subjects affected / exposed	2 / 71 (2.82%)	2 / 70 (2.86%)	3 / 68 (4.41%)	4 / 68 (5.88%)	0 / 69 (0.00%)
occurrences all number	2	2	3	4	0
Nasopharyngitis
subjects affected / exposed	5 / 71 (7.04%)	6 / 70 (8.57%)	8 / 68 (11.76%)	4 / 68 (5.88%)	9 / 69 (13.04%)
occurrences all number	5	8	11	4	18
Pharyngitis
subjects affected / exposed	4 / 71 (5.63%)	3 / 70 (4.29%)	7 / 68 (10.29%)	5 / 68 (7.35%)	2 / 69 (2.90%)
occurrences all number	6	4	8	6	3
Upper respiratory tract infection
subjects affected / exposed	3 / 71 (4.23%)	9 / 70 (12.86%)	7 / 68 (10.29%)	3 / 68 (4.41%)	7 / 69 (10.14%)
occurrences all number	3	9	8	3	7
Urinary tract infection
subjects affected / exposed	4 / 71 (5.63%)	11 / 70 (15.71%)	9 / 68 (13.24%)	11 / 68 (16.18%)	6 / 69 (8.70%)
occurrences all number	4	12	10	16	6
Vaginal infection
subjects affected / exposed	1 / 71 (1.41%)	1 / 70 (1.43%)	0 / 68 (0.00%)	5 / 68 (7.35%)	2 / 69 (2.90%)
occurrences all number	1	1	0	5	2
Metabolism and nutrition disorders
Hypertriglyceridaemia
subjects affected / exposed	1 / 71 (1.41%)	2 / 70 (2.86%)	4 / 68 (5.88%)	4 / 68 (5.88%)	4 / 69 (5.80%)
occurrences all number	2	2	4	4	4

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Were there any global substantial amendments to the protocol? Yes

28 Apr 2015

The main purposes of this amendment are to 10 add a long term extension (LTE), 2) address regulatory requests, 3) update the generic name. In addition, editorial adjustments to provide clarification or fix typographical errors.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of subjects who achieve BICLA response (BICLA response rate) at Day 169.

Primary: Percentage of subjects who achieve BICLA response (BICLA response rate) at Day 169.

Secondary: Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 169

Secondary: Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 169

Secondary: Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 85

Secondary: Percentage of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)], SRI(5) and SRI(6) at Day 85

Secondary: Percentage of subjects with BICLA response (BICLA response rate) at Day 85

Secondary: Percentage of subjects with BICLA response (BICLA response rate) at Day 85

Secondary: Mean change from baseline in CLASI score

Secondary: Mean change from baseline in CLASI score

Secondary: Percentage of subjects with an improvement of >4 or a decrease of >50% from baseline in their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score

Secondary: Percentage of subjects with an improvement of >4 or a decrease of >50% from baseline in their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score

Secondary: Change from baseline in arthritis, as assessed by American College of Rheumatology (ACR) 28-joint count of tender and swollen joints

Secondary: Change from baseline in arthritis, as assessed by American College of Rheumatology (ACR) 28-joint count of tender and swollen joints

Secondary: Change from baseline in BILAG-2004 score of systemic lupus erythematosus (SLE) activity over time

Secondary: Change from baseline in BILAG-2004 score of systemic lupus erythematosus (SLE) activity over time

Secondary: Cumulative corticosteroid and immunosuppressant use over time

Secondary: Cumulative corticosteroid and immunosuppressant use over time

Secondary: Number of subjects with Adverse Events (AEs), Serious adverse events (SAEs), and pre-established Events of Special Interest

Secondary: Number of subjects with Adverse Events (AEs), Serious adverse events (SAEs), and pre-established Events of Special Interest

Secondary: Percentage of subjects with clinically significant changes in vital signs

Secondary: Percentage of subjects with clinically significant changes in vital signs

Secondary: Number of subjects with clinically significant electrocardiogram (ECG) abnormalities

Secondary: Number of subjects with clinically significant electrocardiogram (ECG) abnormalities

Secondary: Ctrough: Trough level serum concentration of BMS-931699 at time points specified

Secondary: Ctrough: Trough level serum concentration of BMS-931699 at time points specified

Secondary: Serum biomarkers C3, C4

Secondary: Serum biomarkers C3, C4

Secondary: Serum biomarkers: Anti-Nuclear Antibodies (ANA)

Secondary: Serum biomarkers: Anti-Nuclear Antibodies (ANA)

Secondary: Short term: Receptor occupancy over time

Secondary: Short term: Receptor occupancy over time

Secondary: Percentage of subjects with BMS-931699 induced antibody response over time point specified

Secondary: Percentage of subjects with BMS-931699 induced antibody response over time point specified

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY I

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY I

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY II

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: HEMATOLOGY II

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : LIVER FUNCTION TESTS

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : LIVER FUNCTION TESTS

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: KIDNEY FUNCTION TESTS

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: KIDNEY FUNCTION TESTS

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests ELECTROLYTES 1

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests ELECTROLYTES 1

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 2

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 2

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 3

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests: ELECTROLYTES 3

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 1

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 1

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 2

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 2

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 3

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : OTHER CHEMISTRY TESTING 3

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : IMMUNOLOGY

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : IMMUNOLOGY

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : URINALYSIS

Secondary: Number of subjects with clinically significant abnormalities in general laboratory tests : URINALYSIS

Secondary: Change from baseline in the SLEDAI-2K score of SLE activity over time

Secondary: Change from baseline in the SLEDAI-2K score of SLE activity over time

Secondary: Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) over time

Secondary: Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) over time

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus